Staff Validation Engineer required for a international engineering company.
Essential Duties and Responsibilities may include, but are not limited to, the following:
Responsible for preparing and executing commissioning, qualification, and validation for new products, processes, equipment and industrial software as well as assisting in maintaining them in a validated state.
Supports validation activities in a GMP regulated manufacturing environment. The Validation engineers will prepare, review, and execute commissioning, qualification (IQ, OQ, PQ), and validation (PV and CV) documents for products, facilities, processes, software and equipment.
Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations.
Aids in the planning of commissioning, qualification and validation activities and in interfacing with QA, Production Operators, and Engineering
Ability to handle multiple commissioning, qualification, validation priorities based on the needs of the manufacturing area with guidance from management.
Education and Experience:
Bachelor’s degree in Engineering or related field, or equivalent combination of education and work-related experience, required.